IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
NCT ID: NCT04598061
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
210 participants
OBSERVATIONAL
2020-10-01
2023-11-28
Brief Summary
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* Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
* The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
* Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
* Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
* The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery
Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery
Dexmedetomidine IV
Dexmedetomidine IV
Interventions
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Dexmedetomidine IV
Dexmedetomidine IV
Eligibility Criteria
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Inclusion Criteria
* less than 7 kg
* Infra-umbilical surgery less than 1 hour
* Spinal anesthesia
Exclusion Criteria
* Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
* Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Chrystelle SOLA, PH
Role: STUDY_DIRECTOR
UH Montpellier
Locations
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University Hospital
Montpellier, Hérault, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECHMPL20_0521
Identifier Type: -
Identifier Source: org_study_id
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